FDA UDI
In Commercial Distribution
🇺🇸 United States
Affymetrix
DI: 00856826006050
·
Model: 2.1
·
AFFYMETRIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Affymetrix
- Primary DI
- 00856826006050
- Version / Model
- 2.1
- Catalog Number
- 610533
- Company Name
- AFFYMETRIX, INC.
- Labeler DUNS
- 804682573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7306debe-e1d1-42ab-aa2f-f5e9cc9b9756
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58047 | Laboratory instrument application software IVD | An individual software program or group of programs, routines or algorithms that add specific data communication, display, processing and/or system integration capabilities to one or more pre-analytical laboratory processing functions (eg. robotic specimen transfer, aliquoting, pipetting, serial dilutions, reagent dispensing, etc) and assay processing functions (microplate washing, incubation control, plate agitation etc) using a series of programmable sequences and data communication facilities to achieve semi-automated throughput. The program applications are restricted to instrument operations and do not generally include data reduction, result interpretation or reporting facilities. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856826006050 | GS1 |